LivaNova Concludes PRELUDE Study for Caisson TMVR System
August 6, 2018—LivaNova PLC announced the conclusion of the PRELUDE feasibility study for its Caisson transcatheter mitral valve replacement (TMVR) system. The PRELUDE first-in-human study evaluated the Company’s TMVR system to treat moderate to severe mitral regurgitation (MR) using a transseptal approach.
After the positive patient outcomes from the PRELUDE study, the company will now focus on enrolling patients in the INTERLUDE CE Mark trial and finalizing the protocol for the ENSEMBLE United States pivotal trial with the FDA. The INTERLUDE trial will be conducted in North American and European centers with enrollment completion expected by 2020.
The PRELUDE study's Principal Investigator, Mathew Williams, MD, commented in the company's announcement, “Patients with moderate-to-severe mitral regurgitation are often too sick for traditional open-heart surgery. We saw encouraging outcomes in patients within the PRELUDE trial. Follow-up results showed positive acute valve performance, which was maintained over time, along with improved quality of life.” Dr. Williams added, “We are pleased to continue our TMVR research with the INTERLUDE trial.”